Characteristics of Spiking in Ghent: a Multicentric Prospective Observational Study..

NCT06207396 | Completed

• 1 other identifier: ONZ-2023-0004
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 4

Brief Summary

This study aims to document the incidence and characteristics of spiking in the Ghent region, both anamnestically and by toxicological analysis. Spiking will be analyzed by immunoassay testing and high-resolution screening according to the protocol in the laboratory of UZ Gent;

Conditions

Unintended Ingestion of Product; Intoxication

Outcome Measures

Primary Outcomes (4)

• What is the incidence of spiking in adult patients presenting to the emergency departments of the four Ghent hospitals with suspected spiking?

  Number of patients presenting to the ED with spiking

  19 months

• What is the type of product and mode of administration used in spiking

  Defining type of products and mode of administration

  19 months

• What are patient characteristics of patients with spiking

  Demographic features of the patients diagnosed with spiking

  19 months

• In what type of places does spiking occur in Ghent

  Location of spiking event

  19 months

Interventions

serum and urine analysis DIAGNOSTIC_TEST

Spiking will be analyzed by immunoassay testing and high-resolution screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult population (18+, all genders) presenting with alleged spiking to the emergency department

You may qualify if:

• \>18 years
• Patient self-reports suspicion of spiking OR there is a suspicion of spiking by physician, police, paramedics or patient's companions
• willingness to provide urine and/or blood samples (depending on timing after event)

You may not qualify if:

• Reporting more than 5 days after spiking
• Unable to reliably complete the questionnaire (can be after clinical observation/recovery).
• Not declaring proficiency in the language in which informed consent is offered (Dutch/English).
• Not agreeing to the informed consent.
• Do not consent to blood and urine collection and/or analysis.
• There is a suspicion of Drug Facilitated Sexual Assault (to be referred to Care Center Sexual Violence, ZSG, where parallel study is ongoing).

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (4)

AZ Maria Middelares

Ghent, 9000, Belgium

Location

Spoedgevallendienst AZ Jan Palfijn

Ghent, 9000, Belgium

Location

Spoedgevallendienst AZ St. Lucas

Ghent, 9000, Belgium

Location

Spoedgevallendienst

Ghent, 9000, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and/or urine

MeSH Terms

Interventions

Urinalysis

Intervention Hierarchy (Ancestors)

Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 17, 2024
• Study Start: June 1, 2023
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

BE (4)